GE Carescape V100 User manual

GE Healthcare

HISTORY

AUTO CYCLE

MAP/Cuff

BATTERY OK

BATTERY LOW CHARGING

Pul se Rat e

Temperature

Sp O

Silence

Alarms

Cycle

History

To clear hold 2 seconds

On / Off

Inflate/Stop

HIGH

LOW

Diastolic

Syst ol ic

HIGH

LOW

HIGH

LOW

ALARM VOLUME PULSE VOLUME

INFLATE PRESSURE

NEONATE

ADULT

CARESCAPE

V100 Vital Signs Monitor

Operator’s Manual

Software Version R1.5

NOTE: The information in this manual applies to CARESCAPE V100 Vital Signs Monitor software version R1.5. Due to

continuing product innovation, specifications in this manual are subject to change without notice.

NOTE: For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems

Information Technologies, Inc.

Listed below are GE Medical Systems Information Technologies, Inc. trademarks. All other trademarks contained herein are the property of their respective owners.

Ohmeda Oximetry and other trademarks (OxyTip+, PI

, TruSat, TruSignal, TruTrak+) are the property of GE Medical Systems

Information Technologies, Inc., a division of General Electric Corporation. All other product and company names are the property of their respective owners.

CARESCAPE, CRITIKON, DINAMAP, DURA-CUF, SOFT-CUF Blood Pressure Cuffs, and SuperSTAT are trademarks of GE Medical Systems Information Technologies, Inc.

Turbo Temp™, Alaris

Tri-Site, and IVAC are trademarks of CareFusion Corporation.

Exergen and TAT-5000 are trademarks of Exergen Corporation.

is a trademark of Surgikos, Inc.

Cidex

Betadine

is a trademark of Purdue-Frederick.

Masimo SET, LNOP, and LNCS are trademarks of Masimo Corporation. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to the device.

Nellcor, OxiMax, C-LOCK and SatSeconds are trademarks of Nellcor Puritan Bennett.

T-2 CARESCAPE V100 Vital Signs Monitor 2048723-001A

19 April 2010

1 Introduction . . . . . . . . . . . . . . . . . . . . . . 1-1

About this device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Safety message signal words . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Product compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

CARESCAPE V100 vital signs monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

Exergen temporal scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

CARESCAPE V100 vital signs monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

Exergen temporal scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

About this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Printed copies of this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Conventions used in this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Revision history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

2 Getting started . . . . . . . . . . . . . . . . . . . 2-1

Unpacking the monitor and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Setting up NIBP connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Setting up SpO2 connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Setting up temperature connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Alaris . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Exergen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Setting up the printer (installing the paper) . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Power sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Turning the monitor on and off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Automatic shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7

Procedure for testing alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Configuration mode settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Entering configuration mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8

2048723-001A CARESCAPE V100 Vital Signs Monitor i

Configuring the default vital sign alarm limits . . . . . . . . . . . . . . . . . . . . . . 2-10

Setting the date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

SpO2 configuration settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Temperature hardware configuration settings . . . . . . . . . . . . . . . . . . . . . 2-13

Advanced configuration mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Entering advanced configuration mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Printing the failure alarm history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

3 Product overview . . . . . . . . . . . . . . . . . 3-1

Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Rear panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Right-side panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Operating (system) modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Clinical mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Configuration mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Advanced configuration mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Service mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Battery low shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

System failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

User modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Menu mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Cycle mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Limit adjustment mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

History mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Start-up sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

User interaction sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Alarm sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Battery low shutdown and system failure sounds . . . . . . . . . . . . . . . . . . 3-12

Battery charger sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Power sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

ii CARESCAPE V100 Vital Signs Monitor 2048723-001A

4 Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Installing the paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Print button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Current (real time) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Clinical history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Failure alarm history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Paper storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

5 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Alarm conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Physiological alarm conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Technical alarm conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

System failure alarm conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4

Alarm modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

IEC alarm mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4

Legacy alarm mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4

Alarm signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Audible alarm signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5

Visual alarm signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5

Silencing an alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Acknowledging an alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Adjusting vital sign alarm limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Adjusting the alarm volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Alarms and priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Factory default . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

2048723-001A CARESCAPE V100 Vital Signs Monitor iii

6 History . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Buttons associated with history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Erasing stored history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Windows associated with history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Indicators associated with history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

7 NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

What is the difference between intra-arterial and auscultatory

methods? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Buttons associated with NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Inflate/Stop button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Cycle button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Windows associated with NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Indicators associated with NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

NIBP modes of operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

Manual NIBP determinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

Auto cycle determinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

Stat NIBP determinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

User settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Mode settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Limit settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Menu settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Sounds associated with NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11

Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11

Checking the monitor’s NIBP technology configuration setting . . . . . 7-11

Taking NIBP measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12

What to do when taking NIBPs on different patients . . . . . . . . . . . . . . . 7-14

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15

Factory defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16

GE Medical Systems Information Technologies, Inc. patents . . . . . . . . . 7-16

iv CARESCAPE V100 Vital Signs Monitor 2048723-001A

8 Ohmeda TruSignal SpO2 . . . . . . . . . . . 8-1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

TruSignal enhanced SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

Configuration settings associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . 8-5

Buttons associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Windows associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Indicators associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

User settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

Limit settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6

Menu settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

Sounds associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8

SpO2 hold-off period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8

Alarm timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-9

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9

Factory default settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10

GE Medical Systems Information Technologies, Inc. patents . . . . . . . . 8-10

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11

9 Nellcor OxiMax SpO2 . . . . . . . . . . . . . . 9-1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Configuration settings associated with SpO

SatSeconds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5

Buttons associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

Windows associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

Indicators associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

User settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Limit settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6

Menu settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Sounds associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8

2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9-4

2048723-001A CARESCAPE V100 Vital Signs Monitor v

SpO2 hold-off period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8

Alarm timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

Factory default settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11

Nellcor patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12

10 Masimo SET SpO2 . . . . . . . . . . . . . . . . 10-1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

Indications and contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

Configuration settings associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . 10-5

Buttons associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Windows associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

Indicators associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

User settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

Limit settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

Menu settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

Sounds associated with SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8

SpO2 hold-off period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8

Alarm timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9

Factory default settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11

Masimo patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12

vi CARESCAPE V100 Vital Signs Monitor 2048723-001A

11 Alaris Temperature – Turbo Temp and

Tri-Site . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

Alaris Turbo Temp or Tri-Site temperature options . . . . . . . . . . . . . . . . . 11-2

Temperature measurement modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Calibration and self-checks of Alaris Turbo Temp or Tri-Site

temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Configuration settings associated with Alaris Turbo Temp and

Tri-Site temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Buttons associated with temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Windows associated with temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Indicators associated with temperature . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Measurement in progress indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Measurement not in progress indicators . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8

User settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8

Menu settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8

Sounds associated with Alaris temperature probes . . . . . . . . . . . . . . . . 11-8

Protective thermometer probe covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9

Alaris thermometer probe covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9

Proper storage of thermometer probe covers . . . . . . . . . . . . . . . . . . . . . 11-9

Guidelines for Alaris temperature measurements . . . . . . . . . . . . . . . . 11-10

Procedures for oral fast (predictive) temperature measurements . . 11-12

Checking the monitor’s Alaris temperature technology

configuration setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12

Taking oral fast (predictive) temperature measurements . . . . . . . . . . 11-12

Procedures for rectal fast (predictive) temperature measurements 11-15

Checking the monitor’s Alaris temperature technology

configuration setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15

Taking rectal fast (predictive) temperature measurements . . . . . . . . 11-15

Procedures for axillary temperature measurements . . . . . . . . . . . . . . 11-18

Checking the monitor’s Alaris temperature technology

configuration setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-18

Taking axillary temperature measurements . . . . . . . . . . . . . . . . . . . . . . 11-19

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-21

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-22

Factory default settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-23

2048723-001A CARESCAPE V100 Vital Signs Monitor vii

12 Exergen Temperature . . . . . . . . . . . . 12-1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2

Temperature measurement mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3

Configuration settings associated with Exergen temperature . . . . . . . 12-4

Buttons associated with temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4

Windows associated with temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4

Indicators associated with temperature . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4

Measurement in progress indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4

Measurement not in progress indicators . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5

Additional indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5

User settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5

Menu settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5

Sounds associated with Exergen temporal scanner . . . . . . . . . . . . . . . . 12-5

Procedures for temperature determination . . . . . . . . . . . . . . . . . . . . . . . 12-6

Familiarize yourself with the scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6

Basics of using the temporal scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6

Alternate sites when temporal artery or behind ear is unavailable . . 12-9

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13

Factory default settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13

Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13

13 Pulse Rate . . . . . . . . . . . . . . . . . . . . . . . 13-1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2

Buttons associated with pulse rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2

Windows associated with pulse rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2

Indicators associated with pulse rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3

User settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3

Limit settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3

Menu settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3

Sounds associated with pulse rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3

Factory defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3

viii CARESCAPE V100 Vital Signs Monitor 2048723-001A

14 Battery . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2

Buttons associated with the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3

Windows associated with the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3

Indicators associated with the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3

First use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3

Battery charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3

Disposal of batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4

Storage, care, and replacement of batteries . . . . . . . . . . . . . . . . . . . . . . 14-4

Battery alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-5

Battery low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-5

E13 BATTERY LOW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-6

Battery specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-6

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-7

A Connections . . . . . . . . . . . . . . . . . . . . . . A-1

Host port connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

B Accessories . . . . . . . . . . . . . . . . . . . . . . . B-1

NIBP accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

SpO2 - Ohmeda accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8

SpO2 - Nellcor accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9

SpO2 - Masimo accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-10

Temperature accessories - Alaris . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11

Temperature accessories - Exergen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-12

Power accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-12

Printer accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-13

Mounting accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-13

Connectivity accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-13

2048723-001A CARESCAPE V100 Vital Signs Monitor ix

C Maintenance . . . . . . . . . . . . . . . . . . . . . C-1

Assistance and parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Maintenance, calibration, and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Calibration and leak testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Battery and storage care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7

Extended battery storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-8

Replacing the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-8

Repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-10

Packaging material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-10

Packing instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-11

Disposal of product waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-11

Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-11

Patient applied parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-11

Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-12

D Principles of Noninvasive Blood Pressure

Determination . . . . . . . . . . . . . . . . . . . . D-1

DINAMAP SuperSTAT algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2

Systolic search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

DINAMAP Classic and auscultatory reference algorithm . . . . . . . . . . . . . D-4

Systolic search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5

Reference used to determine NIBP accuracy . . . . . . . . . . . . . . . . . . . . . . . D-6

x CARESCAPE V100 Vital Signs Monitor 2048723-001A

1 Introduction

2048723-001A CARESCAPE V100 Vital Signs Monitor 1-1

About this device

Introduction: About this device

The CARESCAPE V100 vital signs monitor provides a small, portable, easy-to-use monitoring alternative for sub-acute hospital and non-hospital settings. The monitor is for use on adult, pediatric, or neonatal patients—one at a time. The battery-operated monitor offers noninvasive determination of systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, oxygen saturation, and temperature. Monitors are available with or without integrated printers as well as the following parameters and technologies.

 NIBP, Pulse: SuperSTAT, Auscultatory, or Classic  SpO

 Temperature: Alaris Turbo Temp, Alaris Tri-Site, or Exergen

The model of the CARESCAPE V100 vital signs monitor determines which parameters are in your monitor. Please refer to applicable sections.

Using the CARESCAPE V100 vital signs monitor, a clinician can measure, display, and record patient vital sign data that is derived from each parameter. The monitor is also capable of alerting the clinician to changes in the patient’s condition or when it is unable to effectively monitor the patient’s condition. The monitor also detects alarm limit conditions and gives audible and visual notification of these conditions. All of the main operations of the monitor are easy-to-use and only a button-touch away. Please review the factory default settings and, where applicable, enter settings appropriate for your use.

: Ohmeda TruSignal, Nellcor OxiMax, or Masimo SET

Indications for use

The CARESCAPE V100 vital signs monitor is for use as prescribed by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other qualified medical personnel trained in the use of the equipment. The CARESCAPE V100 vital signs monitor is intended to monitor and measure oscillometric noninvasive blood pressure (systolic, diastolic, and mean blood pressure), heart rate/pulse, oxygen saturation (SpO

oximetry, and temperature using fast predictive mode or continuous monitor mode. An interface to the Exergen TAT-5000 temporal scanner is also provided. Using this monitor, a clinician can view, record, and recall clinical data derived from each parameter.

CARESCAPE V100 vital signs monitors are intended for use in various markets, from the physician’s office to sub-acute triage and medical/surgical units. The CARESCAPE V100 vital signs monitor is intended to monitor one patient at a time in a clinical setting.

) by noninvasive pulse

1-2 CARESCAPE V100 Vital Signs Monitor 2048723-001A

Introduction: Safety message signal words

Safety message signal words

Safety message signal words designate the severity of a potential hazard.

Danger: Indicates a hazardous situation that, if not avoided, will result in death or serious injury.

Warning: Indicates a hazardous situation that, if not avoided, could result in death or serious injury.

Caution: Indicates a hazardous situation that, if not avoided, could result in minor or moderate injury.

Contraindications

This device is not designed, sold, or intended for use except as indicated.

WARNINGS

To avoid personal injury, do not perform any servicing unless qualified to do so.

If powering the monitor from an external power adapter or converter, use only GE-approved power adapters and converters.

Carefully route the external AC/DC power converter, air hoses, and all cables to reduce the possibility of entanglement or strangulation.

Do not immerse monitor in water. If monitor is splashed with water or becomes wet, wipe it immediately with a dry cloth.

Do not immerse sensors in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof).

Examine the power cord periodically. Discontinue use and replace if damaged. Replace the power cord, as necessary, with a regulatory-approved cord for the country of use.

Avoid swinging the monitor, or entangling the monitor and its accessories with a mount or roll-stand, as this could cause the monitor to drop, leading to patient or user injury, and equipment damage.

If any of the seven-segment indicator lights fails to illuminate during the display test, the accuracy of vital sign values could be misread. This indicates problems with the display. Contact GE Technical Support.

Do not perform any testing or maintenance on a sensor while it is being used to monitor a patient.

2048723-001A CARESCAPE V100 Vital Signs Monitor 1-3

Introduction: Contraindications

WARNINGS

Verify calibration of NIBP parameter (temperature and pulse oximeter do not require calibration; refer to the service manual for instructions).

The monitor should only be used by people who have familiarized themselves with its operation.

Keep the monitor and its accessories out of the patient’s reach when not in use.

Place the monitor on a rigid, secure surface or use the monitor with mounting hardware, poles, and stands recommended by GE.

Only use the monitor in areas where adequate ventilation exists.

Do not use any battery other than a GE recommended battery. Other batteries may not provide the same operating time and may cause unexpected monitor shut-down. Other batteries may be incompatible with the internal charger and may cause battery acid leakage, fire, or explosion.

Caution should be taken to not set alarm limits to extreme values, as this can render the alarm system useless.

CAUTIONS

Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

The performance of the monitor may be degraded if it is operated or stored outside of the environmental conditions specified in this manual.

The monitor meets standards IEC 60601-1 and ISO 9919 for shock and vibration. If the monitor is subjected to conditions exceeding these standards, performance may be degraded.

Do not use the monitor in the presence of magnetic resonance imaging (MRI) devices. There have been reports of sensors causing patient burns when operating in an MRI environment.

Do not use the monitor in the presence of flammable anesthetics.

Do not use in the presence of an oxygen-enriched atmosphere (oxygen tent).

1-4 CARESCAPE V100 Vital Signs Monitor 2048723-001A

Introduction: Contraindications

CAUTIONS

Operating the monitor near equipment which radiates highenergy electromagnetic and radio frequencies (electrosurgical/ cauterizing equipment, portable radios, cellular telephones, etc.) may cause false alarm conditions. If this happens, reposition the monitor and temperature probe away from the source of interference and perform a new measurement.

Do not gas sterilize or autoclave the monitor.

The monitor should not be used on patients who are connected to cardiopulmonary bypass machines.

The monitor does not include any user-replaceable fuses. Refer servicing to qualified service personnel.

To reduce the risk of electric shock, do not remove the cover or the back. Refer servicing to a qualified service person.

If the accuracy of any determination reading is questionable, first check the patient’s vital signs by alternate means and then check the monitor for proper functioning.

To help prevent unintended current return paths with the use of high frequency (HF) surgical equipment , ensure that the HF surgical neutral electrode is properly connected.

Do not exceed a load weighing 5 lb. (2.7 kg) in the accessory basket.

To prevent cross-contamination, clean exterior surfaces of the monitor, monitor accessories, and reusable sensors on a regular basis in compliance with your institution's infection control unit and/or biomedical department's local policy.

Do not disassemble the monitor as personal injury may result.

NOTES

 This equipment is suitable for use in the presence of electrosurgery.  The use of approved accessories will provide protection from burns during

high frequency surgery.

2048723-001A CARESCAPE V100 Vital Signs Monitor 1-5

Introduction: Product compliance

Product compliance

CARESCAPE V100 vital signs monitor

Compliance classifications

The monitor is classified in the following categories for compliance with IEC 60601-1:

 Internally powered or Class II when powered from external supply.  Transportable.  For continuous operation.  Not suitable for use in the presence of flammable anesthetics.  Not for use in the presence of an oxygen-enriched atmosphere (oxygen

tent).

 Type BF defibrillator-proof applied parts.  IPX1, degree of protection against ingress of water.  Sterilization/Disinfection, refer to Appendix C, “Maintenance” .  Software is developed in accordance with IEC 60601-1-4.  The monitor complies to IEC 60601-2-49.  The alarm system is developed in accordance with IEC 60601-1-8.  This equipment is suitable for connection to public mains via power.

adapters as defined in CISPR 11.

 The SpO

 The NIBP parameter complies to IEC 60601-2-30, EN 1060-1, EN 1060-3, and

ANSI/AAMI SP10.

 The Temperature parameter complies to ASTM E-1112-00.  Defibrillation protected. When used with the recommended accessories, the

monitor is protected against the effects of defibrillator discharge. If monitoring is disrupted by the defibrillation, the monitor will recover.

 This product conforms with the essential requirements of the Medical

Device Directive 93/42/EEC. Accessories without the CE mark are not guaranteed to meet the Essential Requirements of the Medical Device Directive.

parameter complies to ISO 9919.

1-6 CARESCAPE V100 Vital Signs Monitor 2048723-001A

Introduction: Product compliance

Electromagnetic compatibility (EMC)

WARNINGS

Use of known RF sources, such as cell/portable phones, or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation of this device/ system. Consult qualified personnel regarding device/system configuration.

Use only approved accessories, including mounts and defibrillator-proof cables. For a list of approved accessories, see the supplies and accessories list delivered with the manual. Other cables and accessories may cause a safety hazard, damage the equipment or system, result in increased emissions or decreased immunity of the equipment or system or interfere with the measurement.

CAUTIONS

The equipment or system should not be used adjacent to, or stacked with, other equipment . If adjacent or stacked use is necessary, the equipment or system should be tested to verify normal operation in the configuration in which it is being used.

EMC — Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. Changes or modifications to this device/system not expressly approved by GE Healthcare may cause EMC issues with this or other equipment . This device/system is designed and tested to comply with applicable standards and regulations regarding EMC and needs to be installed and put into service according to the EMC information stated as follows: This device/system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Mains power should be that of a typical commercial or hospital environment.

NOTE

Medical electrical equipment require special electromagnetic compatibility (EMC) precautions which must be considered when installing and putting this equipment into operation. Refer to the service manual for information.

2048723-001A CARESCAPE V100 Vital Signs Monitor 1-7

Introduction: Symbols

Exergen temporal scanner

The Exergen temporal scanner has these additional classifications:

 Type BF applied part  Internally powered (battery operated)  IPX0, degree of protection against ingress of water

Symbols

The following symbols are associated with the monitor and Exergen temporal scanner.

CARESCAPE V100 vital signs monitor

NOTE

The model of the monitor determines which symbols appear on it .

Attention, consult accompanying documents

Silence

Alarms Silence

+ / - Increase / decrease adjustable settings

Inflate/Stop

On/Off

Battery Power

External communications port connector

Charging

External DC power input

Class II equipment

1-8 CARESCAPE V100 Vital Signs Monitor 2048723-001A

Introduction: Symbols

2006-12

IPX1

Defibrillator-proof type BF equipment

WASTE OF ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE): This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

Manufacturer: This symbol is accompanied by the name and the address of the manufacturer.

Manufacturing Date: This symbol is accompanied by the date of the manufacturing.

European authorized representative.

Classified with respect to electric shock, fire, and mechanical and other specified hazards only in accordance with CAN/CSA C22.2 No.

601.1 and UL 2601-1 (UL 60601-1). Also evaluated to IEC 60601-2-30.

This product conforms with the essential requirements of the Medical Device Directive 93/42/EEC. Accessories without the CE mark are not guaranteed to meet the Essential Requirements of the Medical Device Directive.

This product is protected against vertically falling drops of water and conforms with the IEC 60529 Standard at level of IPX1. No harmful effects will come of vertically falling drops of water making contact with the monitor.

FDA Prescriptive Device symbol for: “Caution: Federal law restricts this device to sale by or on the order of a physician.”.

Catalog or orderable part number.

Device serial number.

Russia only. GOST-R mark.

2048723-001A CARESCAPE V100 Vital Signs Monitor 1-9

Introduction: Symbols

Consult instructions for use.

The PSE mark (Product Safety Electric Appliance and Materials) is a mandatory mark required on Electrical Appliances in Japan as authorized by the Electrical Appliance and Material Safety Law (DENAN).This mark signifies that a product complies with the law according to a set of standards for electric devices.

Atmospheric pressure limitations.

Fragile. Handle with care.

Humidity limitations.

Temperature limitations.

CAUTION

— Safety ground precaution. Remove power cord

from the mains source by grasping the plug. Do not pull on the cable.

1-10 CARESCAPE V100 Vital Signs Monitor 2048723-001A

Exergen temporal scanner

2006-12

IPX0

Introduction: About this manual

Attention, consult accompanying documents.

Type BF Applied Part.

Manufacturer: This symbol is accompanied by the name and the address of the manufacturer.

Manufacturing Date: This symbol is accompanied by the date of the manufacturing.

About this manual

Printed copies of this manual

A paper copy of this manual will be provided upon request. Contact your local GE representative and request the part number on the first page of the manual.

Ordinary Equipment.

“On” (only for part of Equipment)

2048723-001A CARESCAPE V100 Vital Signs Monitor 1-11

Introduction: About this manual

Conventions used in this manual

Within this manual, special styles and formats are used to distinguish between terms viewed on screen, a button you must press, or a list of menu commands you must select:

 For technical documentation purposes, the abbreviation GE is used for the

legal entity name, GE Medical Systems Information Technologies, Inc.

 In this manual, the CARESCAPE V100 vital signs monitor is referred to as the

monitor.

 Names of hardware keys on the equipment , keypad, remote control, and

modules are written in bold typeface: Go/Stop.

 Menu items are written in bold italic typeface: Monitor Setup.  Emphasized text is in italic typeface.  Menu options or control settings selected consecutively are separated by

the > symbol: Procedures > Cardiac Output.

 When referring to different sections in this manual, section names are

enclosed in double quotes: “Cleaning and care.”

 The word “select” means choosing and confirming.  Messages (alarm messages, informative messages) displayed on the screen

are written inside single quotes: 'Learning.'

 Note statements provide application tips or other useful information.  Any illustrations appearing in this manual are provided as examples only.

They may not necessarily reflect your monitoring setup or data displayed on your monitor.

 Any names appearing in examples and illustrations are fictitious. The use of

any real person’s name is purely coincidental.

Revision history

Revision Comments

A Initial release of this document.

1-12 CARESCAPE V100 Vital Signs Monitor 2048723-001A

2 Getting started

2048723-001A CARESCAPE V100 Vital Signs Monitor 2-1

Getting started: Unpacking the monitor and accessories

Unpacking the monitor and accessories

Before attempting to use the monitor, take a few minutes to become acquainted with the monitor and its accessories. Unpack the items carefully. This is also a good time to check for any damage or accessory shortage. If there is a problem or shortage, contact GE.

It is recommended that all the packaging be retained, in case the monitor must be returned for service in the future.

Setting up NIBP connections

1. Connect the end of the air hose that has quick-release clips to the NIBP connector on the front of the monitor. Make sure that the hose is not kinked or compressed.

NOTE

To disconnect the hose from the monitor, squeeze the quick-release clips together and pull the plug from the NIBP connector.

2. Select appropriate cuff size. Measure patient’s limb and select appropriately sized cuff according to size marked on cuff or cuff packaging. When cuff sizes overlap for a specified circumference, choose the larger size cuff.

WARNING

Accuracy of NIBP measurement depends on using a cuff of the proper size. It is essential to measure the circumference of the limb and to select the proper size cuff. In addition, the air hoses are color-coded according to patient population. The gray 12or 24-foot hose (3.66 m or 7.3 m) is required on patients who require cuff sizes from infant through thigh cuffs. The light blue 12-foot hose (3.66 m) is required for the neonatal cuff sizes #1 through #5. If it becomes necessary to move the cuff to another limb, make sure the appropriate size cuff is used.

3. Inspect cuff for damage. Replace cuff when aging, tearing, or weak closure is apparent. Do not inflate cuff when unwrapped.

CAUTION

Do not use cuff if structural integrity is suspect.

2-2 CARESCAPE V100 Vital Signs Monitor 2048723-001A

Getting started: Setting up SpO2 connections

4. Connect the cuff to the air hose. Refer to “Chapter 7, “NIBP” ” of this manual for complete cuff connection instructions.

CAUTION

Always use the appropriate hose and cuff combination for the patient. Any attempt to modify the hose may inhibit the monitor from switching between the neonate and adult/ pediatric measurement modes.

NOTE

Care should be taken in reconnecting the cuff to a hose, ensuring that threads of the cuff and hose are in alignment and no cross-threading occurs.

5. Refer to Chapter 7, “NIBP” of this manual for complete instructions on taking an accurate NIBP determination.

NOTES

 Use only GE CRITIKON BP cuffs. The size, shape, and bladder

characteristics can affect the performance of the instrument. Inaccurate readings may occur unless GE CRITIKON Blood Pressure cuffs are used. Refer toAppendix B, “Accessories” for reorder codes.

 The ADULT indicator encompasses both adult and pediatric patients.

Setting up SpO2 connections

1. Plug the appropriate SpO2 sensor into the SpO2 sensor extension cable.

2. Then plug the SpO on the monitor.

3. Refer to the applicable “SpO2” section of this manual for complete instructions on monitoring SpO

sensor extension cable into the SpO2 sensor connector

2048723-001A CARESCAPE V100 Vital Signs Monitor 2-3

Getting started: Setting up temperature connections

Setting up temperature connections

Alaris

1. Connect the temperature probe cable to the temperature probe connector on the monitor.

2. Insert the temperature probe into the probe holster at the side of the monitor.

3. Refer to Chapter 11, “Alaris Temperature

– Turbo Temp and Tri-Site” section of this

manual for complete instructions on taking a temperature reading.

Exergen

NOTE

Specific error messages that display on the scanner’s LED window will not display on the monitor. Instead, error conditions will be indicated on the monitor by ‘E--’.

NOTE

No more than one Exergen scanner should be connected and used with the monitor at a time.

1. Connect the scanner’s modular plug (1) to the Host Communication port (2) at the back of the monitor.

2. Secure the plug using the two thumbscrews on the plug.

3. Refer to Chapter 12,

“Exergen Temperature”

section of this manual for complete instructions on taking a temperature reading.

2-4 CARESCAPE V100 Vital Signs Monitor 2048723-001A

Getting started: Setting up the printer (installing the paper)

Setting up the printer (installing the paper)

1. With the monitor powered on, turn it so that the side with the printer is facing you.

2. While grasping the side of the monitor, lift the printer door open by placing your thumb in the indented area and pulling. The printer door will pop open.

3.Place the roll of paper into the compartment so that the end of the paper comes off the right-side of the roll (paper is wound around the roll clockwise). Place the roll of paper in the holding bracket that is integrated in the door of the printer, making sure the paper extends out of the printer cavity at least two inches.

4.Firmly press the door to close it.

Power sources

The monitor is designed to operate either from an external power source (mains) or from an internal battery. Refer to “Specifications” on page 3-13 for details.

With external DC power connected, the green CHARGING indicator will light to indicate that the battery is charging.

DANGER

ELECTRIC SHOCK — Do not touch the patient and the DC power input connector pins simultaneously.

2048723-001A CARESCAPE V100 Vital Signs Monitor 2-5

Getting started: Turning the monitor on and off

WARNING

Examine the power cord periodically. Discontinue use and replace if damaged. Replace the power cord, as necessary, with a regulatory-approved cord for the country of use.

NOTES

 Be sure to unplug the power supply from the AC outlet before transport.  Even if connected to an external power source, the monitor is not

designed to operate without an internal battery.

Using the power cord supplied with the monitor, connect it to the power line. Use only the original cord, a power cord recommended by GE, or a regulatoryapproved cord for the country of use.

Turning the monitor on and off

To turn the monitor on, push the power On/Off button. As the monitor powers up, it runs a short self-test (display test) in which all seven-segment indicator lights illuminate. When the monitor is powered on, it generates a start-up sound. This start-up sound consists of 5 separate tones generated in succession.

WARNINGS

Inspect the device for damage before use.

If the monitor fails to sound the start-up tones, do not use the monitor. This indicates problems with the audible alarm circuit. Contact GE Technical Support.

To turn the monitor off, push the power On/Off button again. This will terminate any measurements that may be in progress and automatically deflate the cuff.

2-6 CARESCAPE V100 Vital Signs Monitor 2048723-001A

+ 190 hidden pages

GE Carescape V100 User manual

Contents

1 Introduction

About this device

Indications for use

Safety message signal words

Contraindications

Product compliance

CARESCAPE V100 vital signs monitor

Exergen temporal scanner

Symbols

CARESCAPE V100 vital signs monitor

Exergen temporal scanner

About this manual

Printed copies of this manual

Conventions used in this manual

Revision history

2 Getting started

Unpacking the monitor and accessories

Setting up NIBP connections

Setting up SpO2 connections

Setting up temperature connections

Alaris

Exergen

Setting up the printer (installing the paper)

Power sources

Turning the monitor on and off